EP2437819B1 - Boîtier interne pour dispositif d'administration de médicaments - Google Patents

Boîtier interne pour dispositif d'administration de médicaments Download PDF

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Publication number
EP2437819B1
EP2437819B1 EP10722095.6A EP10722095A EP2437819B1 EP 2437819 B1 EP2437819 B1 EP 2437819B1 EP 10722095 A EP10722095 A EP 10722095A EP 2437819 B1 EP2437819 B1 EP 2437819B1
Authority
EP
European Patent Office
Prior art keywords
dose
setting mechanism
dose setting
driver
inner housing
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP10722095.6A
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German (de)
English (en)
Other versions
EP2437819A1 (fr
Inventor
David Plumptre
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sanofi Aventis Deutschland GmbH
Original Assignee
Sanofi Aventis Deutschland GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sanofi Aventis Deutschland GmbH filed Critical Sanofi Aventis Deutschland GmbH
Priority to PL10722095T priority Critical patent/PL2437819T3/pl
Priority to EP18150058.8A priority patent/EP3345639B1/fr
Priority to NO10722095A priority patent/NO2437819T3/no
Priority to EP10722095.6A priority patent/EP2437819B1/fr
Priority to PL18150058T priority patent/PL3345639T3/pl
Priority to DK18150058.8T priority patent/DK3345639T3/da
Publication of EP2437819A1 publication Critical patent/EP2437819A1/fr
Application granted granted Critical
Publication of EP2437819B1 publication Critical patent/EP2437819B1/fr
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Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A61M5/31541—Means preventing setting of a dose beyond the amount remaining in the cartridge
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
    • A61M5/31543—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose piston rod reset means, i.e. means for causing or facilitating retraction of piston rod to its starting position during cartridge change
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • A61M5/31551—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe including axial movement of dose setting member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31583—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
    • A61M5/31585—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod performed by axially moving actuator, e.g. an injection button
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3125—Details specific display means, e.g. to indicate dose setting
    • A61M2005/3126—Specific display means related to dosing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/27—General characteristics of the apparatus preventing use

Definitions

  • the present application is generally directed to dose setting mechanisms for drug delivery devices. More particularly, the present application is generally directed to a dose setting mechanism comprising an inner housing and used for drug delivery devices. Aspects of the invention may be equally applicable in other scenarios as well.
  • Pen type drug delivery devices have application where regular injection by persons without formal medical training occurs. This may be increasingly common among patients having diabetes where self-treatment enables such patients to conduct effective management of their disease.
  • a pen type delivery device There are basically two types of pen type delivery devices: resettable devices (i.e., reusable) and non-resettable (i.e., disposable). These types of pen delivery devices (so named because they often resemble an enlarged fountain pen) are generally comprised of three primary elements: (i) a cartridge section that includes a cartridge often contained within a housing or holder; (ii) a needle assembly connected to one end of the cartridge section; and (iii) a dosing section connected to the other end of the cartridge section.
  • resettable devices i.e., reusable
  • non-resettable i.e., disposable
  • These types of pen delivery devices are generally comprised of three primary elements: (i) a cartridge section that includes a cartridge often contained within a housing or holder; (ii) a needle assembly connected to one end of the cartridge section; and (iii) a dosing section connected to the other end of the cartridge section.
  • a cartridge typically includes a reservoir that is filled with a medication (e.g., insulin), a movable rubber type bung or stopper located at one end of the cartridge reservoir, and a top having a pierceable rubber seal located at the other, often necked-down, end.
  • a medication e.g., insulin
  • a movable rubber type bung or stopper located at one end of the cartridge reservoir
  • a top having a pierceable rubber seal located at the other, often necked-down, end.
  • a crimped annular metal band is typically used to hold the rubber seal in place.
  • the cartridge housing may be typically made of plastic
  • cartridge reservoirs have historically been made of glass.
  • the needle assembly is typically a replaceable double-ended needle assembly. Before an injection, a replaceable double-ended needle assembly is attached to one end of the cartridge assembly, a dose is set, and then a dose is administered. Such removable needle assemblies may be threaded onto, or pushed (i.e., snapped) onto the pierceable seal end of the cartridge assembly.
  • the dosing section or dose setting mechanism is typically the portion of the pen device that is used to set a dose.
  • a spindle contained within the dose setting mechanism presses against the bung or stopper of the cartridge. This force causes the medication contained within the cartridge to be injected through an attached needle assembly. After an injection, as generally recommended by most drug delivery device and/or needle assembly manufacturers and suppliers, the needle assembly is removed and discarded.
  • typical reusable pen delivery devices feature essentially two main reusable components: a cartridge holder and a dose setting mechanism. After a cartridge is inserted into the cartridge holder, this cartridge holder is attached to the dose setting mechanism. The user uses the dose setting mechanism to select a dose. Before the user injects the set dose, a replaceable double-ended needle assembly is attached to the cartridge housing.
  • This needle assembly may be threaded onto or pushed onto (i.e., snapped onto) a distal end of the cartridge housing.
  • a double ended needle mounted on the needle assembly penetrated through a pierceable seal at a distal end of the cartridge.
  • the needle assembly is removed and discarded.
  • the user detaches the cartridge housing from the dose setting mechanism. The user can then remove the empty cartridge from the cartridge retainer and replace the empty cartridge with a new (filled) cartridge.
  • the dose setting mechanism must be reset to a starting or initial position.
  • the spindle that advances in a distal direction during dose injection must somehow be retracted back into the dose setting mechanism.
  • Certain known methods of retracting this spindle back into the dose setting mechanism to a restart or an initial position are known in the art.
  • certain known reset mechanisms require a user to turn back or push back (retract) the spindle or some other portion of the dose setting mechanism.
  • Resetting of known dose setting mechanisms have certain perceived disadvantages.
  • One perceived disadvantage is that the pen device user has to disassemble the device to either remove an empty cartridge or somehow reset the device.
  • another perceived disadvantage is that such devices have a high number of parts and therefore such devices are typically complicated from a manufacturing and from an assembly standpoint.
  • certain typical resettable pen type devices are not intuitive as to how a user must replace an empty cartridge or how a user is to reset the device.
  • such resettable devices use a large number of components parts, such resettable devices tend to be large and bulky, and therefore not easy to carry around or easy to conceal.
  • a dose setting mechanism comprising an inner housing with means for guiding a dial sleeve and/or a driver of said mechanism with the features of claim 1.
  • a dose setting mechanism for a drug delivery device comprises an outer housing and an inner housing having an external groove.
  • the inner housing guides the driver to dispense a dose set by the dose setting mechanism.
  • a dial sleeve is disposed between the outer and inner housing and is rotatably engaged with the external groove of the inner housing. When a dose is set, the dial sleeve is rotated with respect to both the outer housing and the inner housing. The dial sleeve is translated away from both the outer housing and the inner housing.
  • said external groove of said inner housing comprises a helical groove having a constant pitch.
  • the inner housing may comprise an internal surface having a mechanical configuration that guides said driver to dispense said dose set by said dose setting mechanism.
  • said mechanical configuration of said inner housing comprises a spline that guides said driver to dispense said dose set by said dose setting mechanism.
  • said mechanical configuration of said inner housing may comprise a groove that guides said driver to dispense said dose set by said dose setting mechanism.
  • said dial sleeve may have a generally smooth outer surface.
  • a scale arrangement is provided along a portion of said generally smooth outer surface.
  • said scale arrangement provided along said portion of said generally smoother outer surface is viewable only through a window provided in an outer housing of said dose setting mechanism.
  • the dose setting mechanism may be coupled to a cartridge holder.
  • said dose setting mechanism is permanently coupled to said cartridge holder.
  • the dose setting mechanism may further comprise a spindle which is operatively coupled to said driver, such that when said inner housing guides said driver to dispense said dose set by said dose setting mechanism, said driver pushes said spindle to act on a cartridge bung while said spindle translates in a distal direction to expel said dose from said cartridge.
  • a mechanism for setting a dose comprises a spindle for acting on a cartridge bung and a driver cooperating with the spindle.
  • the arrangement also comprises an inner housing having an inner surface. The inner surface of the inner housing dictating movement of the driver during a dose dispensing step so that the spindle acts on the cartridge bung.
  • said inner surface of said inner body comprises at least one longitudinal groove.
  • said inner surface comprises at least a portion of a helical groove.
  • said inner surface may comprise a male groove guide.
  • a drug delivery device comprises an outer body and an inner body having an external helical groove.
  • a dial sleeve is engaged with the external groove of the inner body and positioned between the outer body and the inner body.
  • a driving member is positioned within the inner body.
  • a clutch is operatively coupled to the dial sleeve and the driving member. The clutch allows the dial sleeve and the driving member to rotate together during a setting of a dose of the drug delivery device.
  • a spindle may be provided operatively coupled to said driving member, such during said injection of said dose, said inner body guides said driving member and said driving member driver pushes said spindle to dispel a dose of medication from a cartridge.
  • said spindle may comprise at least one groove, said at least one groove allowing said spindle to translate in a distal direction to expel said dose from said cartridge.
  • a dose setting mechanism for a drug delivery device comprising an outer housing, an inner housing, a driver and a dial sleeve.
  • the inner housing has an external groove, with said inner housing being operatively coupled to the driver and guiding said driver to dispense a dose set by said dose setting mechanism.
  • the dial sleeve is disposed between said outer housing and said inner housing, with the dial sleeve being rotatably engaged with said external groove of said inner housing, such that when a dose is set by said dose setting mechanism, said dial sleeve and driver are both rotated with respect to both said outer housing and said inner housing and are translated away from both said outer housing and said inner housing.
  • the external groove of said inner housing comprises a helical groove having a constant pitch.
  • the inner housing comprises an internal surface, which comprises a mechanical configuration that guides said driver to dispense said dose set by said dose setting mechanism.
  • the mechanical configuration of said inner housing may comprise a spline that guides said driver to dispense said dose set by said dose setting mechanism.
  • the mechanical configuration of said inner housing may comprise a groove that guides said driver to dispense said dose set by said dose setting mechanism.
  • said dial sleeve may have a generally smooth outer surface.
  • a scale arrangement is provided along a portion of said generally smooth outer surface.
  • said scale arrangement provided along said portion of said generally smoother outer surface is viewable only through a window provided in an outer housing of said dose setting mechanism.
  • the dose setting mechanism may be coupled to a cartridge holder.
  • said dose setting mechanism is permanently coupled to said cartridge holder.
  • a spindle is provided, which is operatively coupled to said driver, such that when said inner housing guides said driver to dispense said dose set by said dose setting mechanism, said driver pushes said spindle to act on a cartridge bung while said spindle translates in a distal direction to expel said dose from said cartridge.
  • a further aspect of the present invention is directed to the ratio of the length of the inner housing or body to the length of further components of the dose setting mechanism of a drug delivery device.
  • the inner housing has a length L in its axial direction which is essentially the same as the length of the dose setting mechanism, or the outer housing or the dose dial sleeve.
  • the length L of the inner housing being nealy exactly the same as the length of the outer housing, preferred embodiments include a length L of the inner housing being between about 75 % to about 125 %, preferably between 90 % and 110 %, of the length of the dose setting mechanism, or the outer housing or the dose dial sleeve.
  • the drug delivery device 1 comprises a housing having a first cartridge retaining part 2, and dose setting mechanism 4. A first end of the cartridge retaining part 2 and a second end of the dose setting mechanism 4 are secured together by retaining features. In this illustrated arrangement, the cartridge retaining part 2 is secured within the second end of the dose setting mechanism 4. A removable cap 3 is releasably retained over a second end or distal end of a cartridge retaining part.
  • the dose setting mechanism 4 comprises a dose dial grip 12 and a window or lens 14. To set a dose of medication contained within the drug delivery device 1, a user rotates the dose dial grip 12 and the window allows a user to view the dialed dose by way of a dose scale arrangement 16.
  • Figure 2 illustrates the medical delivery device 1 of Figure 1 with the cover 3 removed from the distal end of the medical delivery device.
  • a cartridge 20 from which a number of doses of a medicinal product may be dispensed is provided in the cartridge housing 6.
  • the cartridge 20 contains a type of medicament that is administered often, such as once or more times a day.
  • the term "medicament”, as used herein, means a pharmaceutical formulation containing at least one pharmaceutically active compound, wherein in one embodiment the pharmaceutically active compound has a molecular weight up to 1500 Da and/or is a peptide, a proteine, a polysaccharide, a vaccine, a DNA, a RNA, a antibody, an enzyme, an antibody, a hormone or an oligonucleotide, or a mixture of the above-mentioned pharmaceutically active compound, wherein in a further embodiment the pharmaceutically active compound is useful for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism, acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis, wherein in a further embodiment the pharmaceutically active
  • Insulin analogues are for example Gly(A21), Arg(B31), Arg(B32) human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.
  • Insulin derivates are for example B29-N-myristoyl-des(B30) human insulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-Y-glutamyl)-des(B30) human insulin; B29-N-(N-lithocholyl-Y-glutamyl)-des(B30) human insulin; B29-N-( ⁇ -carboxyheptadecanoyl)-des(B30) human insulin and B29-N-( ⁇ -carbox
  • Exendin-4 for example means Exendin-4(1-39), a peptide of the sequence H-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.
  • Exendin-4 derivatives are for example selected from the following list of compounds:
  • Hormones are for example hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists as listed in Rote Liste, ed. 2008, Chapter 50 , such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.
  • Gonadotropine Follitropin, Lutropin, Choriongonadotropin, Menotropin
  • Somatropine Somatropin
  • Desmopressin Terlipressin
  • Gonadorelin Triptorelin
  • Leuprorelin Buserelin
  • Nafarelin Goserelin.
  • a polysaccharide is for example a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra low molecular weight heparin or a derivative thereof, or a sulphated, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and/or a pharmaceutically acceptable salt thereof.
  • An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium.
  • Pharmaceutically acceptable salts are for example acid addition salts and basic salts.
  • Acid addition salts are e.g. HCI or HBr salts.
  • Basic salts are e.g. salts having a cation selected from alkali or alkaline, e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1)(R2)(R3)(R4), wherein R1 to R4 independently of each other mean: hydrogen, an optionally substituted C1-C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6-C10-aryl group, or an optionally substituted C6-C10-heteroaryl group.
  • solvates are for example hydrates.
  • a bung or stopper (not illustrated in Figure 2 ) is retained in a first end or a proximal end of the cartridge 20.
  • the dose setting mechanism 4 of the drug delivery device illustrated in Figure 2 may be utilized as a reusable (and hence resettable) or a non-reusable (and hence non-resettable) drug delivery device.
  • the cartridge is removable from the cartridge housing 6.
  • the cartridge 20 may be removed from the device without destroying the device by merely the user disconnecting the dose setting mechanism 4 from the cartridge holder 6.
  • a replaceable cap 3 is used to cover the cartridge holder 6 extending from the dose setting mechanism 4.
  • the outer dimensions of the replaceable cap 3 are similar or identical to the outer dimensions of the dose setting mechanism 4 so as to provide an impression of a unitary whole when the replaceable cap 3 is in position covering the cartridge holder 2.
  • FIG. 3 illustrates a sectional view of the dose setting mechanism 4 removably connected to the cartridge holder 6.
  • the dose setting mechanism 4 comprises an outer housing 40 containing a spindle 42, a number sleeve 24, a clicker 75, a clutch 26, and a driver 30.
  • a first helical groove 19 extends from a first end of a spindle 42.
  • the spindle 42 is generally circular in cross section however other arrangements may also be used.
  • the first end of the spindle 42 (a distal end 43 of the spindle 42) extends through a pressure plate 64.
  • a spindle bearing 50 is located at the distal end 43 of the spindle 42.
  • the spindle bearing 50 is disposed to abut a second end of the cartridge piston 18.
  • the driver 30 extends about the spindle 42.
  • the clutch 26 is disposed about the driver 30, between the driver 30 and a number sleeve 24.
  • the clutch 26 is located adjacent the second end of the driver 30.
  • a number sleeve 24 is provided outside of the clutch 26 and radially inward of the housing 40.
  • the main housing 40 is provided with a window 14 through which a part of an outer surface 11 of the number sleeve 10 may be viewed.
  • a dose dial grip 12 is disposed about an outer surface of the second end of the number sleeve 10.
  • An outer diameter of the dose dial grip 12 preferably corresponds to the outer diameter of the housing 40.
  • the dose dial grip 12 is secured to the number sleeve 10 so as to prevent relative movement between these two components.
  • the dose dial grip 12 and number sleeve 10 comprise a one piece component that is rotationally coupled to a clutch and drive sleeve and axially coupled to the number sleeve 10.
  • alternative coupling arrangements may also be used.
  • driver 30 comprises a first driver portion 44 and a second driver portion 46 and these portions extend about the spindle 42. Both the first and the second driver portions 44, 46 are generally cylindrical. As can be seen from Figure 6 , the first drive portion 44 is provided at a first end with a first radially extending flange 56. A second radially extending flange 58 is provided spaced a distance along the first driver portion 44 from the first flange 56. An intermediate helical groove 62 is provided on an outer part of the first driver portion 44 extending between the first flange 56 and the second flange 58. A portion or a part helical groove 68 extends along an internal surface of the first driver portion 44. The spindle 42 is adapted to work within this part helical groove 68.
  • a dose limiter 38 (illustrated in Figure 3 ) is located between the driver 30 and the housing 4, disposed between the first flange 56 and the second flange 58.
  • the dose limiter 38 comprises a nut.
  • the dose limiter 38 has an internal helical groove matching the helical groove 62 of the driver 30.
  • the outer surface of the dose limiter 38 and an internal surface of the housing 40 are keyed together by way of splines. This prevents relative rotation between the dose limiter 38 and the housing 40 while allowing relative longitudinal movement between these two components.
  • the operation of the dose setting mechanism 4 occurs as follows.
  • a user rotates the dose dial grip 12.
  • the driver 30, the clutch 26 and the number sleeve 10 rotate along with the dose dial grip 12.
  • the clicker 75 is disposed between a distal end 23 of the clutch 26 and a flange 80 of the drive sleeve 46.
  • the clicker 75 and the internal surface of the housing 40 are keyed together by way of splines 65a, 65b. This prevents rotation of the clicker 75 with respect to the housing 40 either during dose selection or during dose administration.
  • the number sleeve 10 extends in a proximal direction away from the housing 40. In this manner, the driver 30 climbs the spindle 42. As the driver 30 and the clutch rotates, a distal portion 23 of the clutch drags over the clicker 75 to produce a click.
  • the distal portion includes a plurality of splines that are disposed such that each click corresponds to a conventional unit dose, or the like.
  • a radial stop on the number sleeve 10 engages either a first stop or a second stop provided on the housing 40 to prevent further movement. Rotation of the spindle 42 is prevented due to the opposing directions of the overhauled and driven threads on the spindle 42.
  • the dose limiter 38 keyed to the housing 40, is advanced along the thread 62 by the rotation of the driver 30.
  • Figure 2 illustrates the medical delivery device after a desired dose of 79 International Units (IU) has been dialed.
  • IU International Units
  • the driver 30 is prevented from rotating with respect to the main housing 40 but it is free to move axially with respect thereto.
  • the longitudinal axial movement of the driver 30 causes the spindle 42 to rotate and thereby to advance the piston 18 in the cartridge 20.
  • the first and second portions 44, 46 of the driver 30 are coupled together when the dose dial sleeve 10 is rotated. That is, in normal use, the first and second portions 44, 46 of the driver 30 are coupled together with the dose dial sleeve 10 when a user sets a dose by turning the dose dial grip 12. After each dispensed dose, the spindle 42 is pushed in a distal direction, acting on the bung 18 of the cartridge 20 to continue to expel a dialed dose of medication out of an attached needle assembly releasably connected to the distal end 8 of the cartridge holder 6.
  • the user may wish to replace the empty cartridge in the cartridge holder 6 with a new cartridge.
  • the user must then also reset the dose setting mechanism 4: for example, the user must then retract or push the spindle 42 back into the dose setting mechanism 4.
  • the first and second driver portions 44, 46 must be de-coupled from one another. After decoupling the first driver portion 44 from the second driver portion 46, the first driver portion 44 will be free to rotate while the second driver portion 46 will not be free to rotate.
  • FIG. 7 illustrates one arrangement for connecting the spindle 42 to the spindle guide 48.
  • the spindle 42 comprises a first spline 51and a second spline 52.
  • the spindle guide 48 comprises an essentially circular member having an aperture. The aperture includes two inner protruding members 55, 57 that engage the first and second splines 51, 52 respectively, so that the spindle guide 48 locks onto the spindle and rotates along with the spindle during spindle rotation.
  • rotation of the first driver portion 44 will also axial move or reset a dose limiter 38 to an initial or start position. That is, as the first driver portion 44 is rotated back to an initial start position, because the dose limiter 38 is threadedly engaged to the outer groove and splined to an inner surface of a housing portion, such as the outer housing 40. In this configuration, the dose limiter 38 is prevented from rotating but will move along the outer groove 62 of the first driver portion 44 as this portion is rotated during a resetting step. In addition, because it is splined to longitudinal splines 65a, 65b of the outer housing 4, the clicker 75 is also prevented from rotating during this resetting step.
  • the two portions of the driver 30 are decoupled when the first driver portion 44 is pulled axially away from the second driver portion 46.
  • a biasing means such as at least one spring
  • the spindle 42 is rotationally locked to this spindle guide 48 and is threadedly engaged with the spindle nut 66, the spindle 42 will move axially.
  • the spindle 42 is coupled via a groove engaged to the first driver portion 44.
  • the first driver portion 44 is prevented from rotation by a clutched connection to the second driver portion 46.
  • the second driver portion 46 is prevented from rotation by the clicker detent 75which resides between the clutch and the flange 80 of the drive sleeve 46. Therefore, axial movement of the spindle 42 decouples the two driver portions 44, 46 so that the clutched connection becomes de-coupled.
  • the various component parts of the drug delivery device include: a dose setting housing 40, a cartridge 20, a spindle 42, first driver portion 44; second driver portion 46, spindle bearing 50, spindle guide 48 a spring plate 54; a main spring 60, a pressure plate 64, a cartridge holder 20; a spindle nut 66; and a second spring 70.
  • the spindle guide 48 is rotationally fixed relative to the spindle 20.
  • the spring plate 54 pressure plate 64 and spindle nut 66 are all rotationally fixed relative to the outer housing.
  • the cartridge holder 6 is fitted via apertures in the pressure plate 64 and applies a load to the spring plate 54. This compresses the first biasing means or main spring 60. These apertures in the pressure plate 64 (not shown) allow the pressure plate 64 to move away from the spring plate 54 (in a distal direction towards the cartridge holder 6) under the action of the second biasing means or second spring 70. This will open up a Gap "a” as shown in Figure 3 .
  • Gap "a” is a gap created between the pressure plate 64 and the spring plate 54.
  • This Gap b is illustrated in Figure 3 .
  • the Gap b in conjunction with the light force from the second spring or biasing means 70 moves the spindle nut 66 towards the distal end of the drug delivery device 1. This applies light pressure to the spindle guide 48.
  • the spindle guide 48 is compressed under the action of the second spring 70 between the spindle nut 66 and pressure plate 64.
  • One advantage of this configuration is that at the end of a dose, it is advantageous to prevent the spindle 42 from back-winding into the dose setting mechanism 4 under light residual loads that may remain from the cartridge bung 18. By preventing the spindle 42 from back-winding in a proximal direction, a distal end 43 of the spindle 42 (and hence the spindle bearing 50) remains on the bung 18. Maintaining the distal end 43 of the spindle 42 on the bung 18 helps to prevent a user from administrating a potential under-dose.
  • FIG 4 illustrates the dose setting mechanism 4 of Figure 3 with the cartridge holder 6 rotated to release a connection type between the housing 40 of dose setting mechanism 4 and the cartridge holder 6.
  • this connection type 22 is a bayonet connection.
  • other connection types 22 may be used as well such as threads, snap locks, snap fits, luer locks and other similar connection types.
  • FIGs 3-5 by rotating the cartridge holder 6 with respect to housing 40, features that were initially acting on the spring plate 54 to compress the main biasing means 60 through apertures in the pressure plate 64, rotate so that they now release this force created by the main biasing means 60. This allows the spring plate 54 to move in a distal direction until the spring plate 54 contacts the spindle nut 66 on an inside face of the spindle nut 66.
  • the cartridge holder 6 disengages from the connection type 22 with the housing 40.
  • the cartridge holder 6 is then driven in an axial direction away from the housing 40 by the main biasing means 60 (i.e., in a distal direction).
  • the main spring 60 continues to load the cartridge holder 6 through the spindle guide 48 and therefore the spindle 42 is prevented from rotation.
  • the spindle 42 is also threaded to the first driver portion 44, the first driver portion 44 is also pulled axially in a distal direction and in this manner becomes disengaged from the second driver portion 46.
  • the second driver portion 46 is axially fixed and is prevented from rotation. In one arrangement, the second driver portion 46 is prevented from rotation by clicker elements and prevented from axial movement by its axial coupling to the number sleeve.
  • Figure 5 illustrates the dose setting mechanism illustrated in Figure 3 in a third position, that is, with the cartridge holder 6 removed.
  • the bayonet features shown in Figure 5 illustrated as round pegs extending radially inwards on inside of inner housing
  • Gap "e” develops.
  • Gap "e” removes the high spring force created by the main biasing means 60 from the spindle guide 48.
  • the dose setting mechanism 4 in Figure 4 is now ready to be reset.
  • a user retracts the spindle 42 in a proximal direction back into the housing 40 by pushing on the distal end 43 of the spindle 42. Therefore, during this re-setting step of the dose setting mechanism 4, as the spindle 42 is pushed back into the dose setting mechanism 4, the movement of the spindle 42 causes the spindle nut 66 to move back against a light spring force created by the second biasing means 70. This movement releases the axial load and hence resistance to rotation from the spindle guide 48. Therefore, as the dose setting mechanism 4 is reset by the spindle 42 rotating back into the dose setting mechanism 4, the spindle guide 48 also rotates.
  • the spindle 42 rotates through the spindle nut 66.
  • the first driver portion 44 is de-coupled from the second driver portion 46, the first driver portion 44 rotates (with the flexible elements 102, 103 running on a conical surface groove 90 formed by the first annular ring 91 on the second half of the drive sleeve 46, Figures 5 and 6 ). This accommodates the axial and rotational movement of the spindle 42.
  • first driver portion 44 As the first driver portion 44 rotates during reset, first driver portion 44 also re-sets the dose nut. More specifically, as the first driver portion 44 rotates, the dose nut which is not rotatable since it is splined to an inner surface of the housing 40, traverses along the helical groove 62 provided along an outer surface of the first driver portion 44 and traverses back to an initial or starting position. In one preferred arrangement, this starting position of the dose nut resides along the first radial 56 flange of the first driver portion 44.
  • the dose setting mechanism 4 After the dose setting mechanism 4 has been reset, the dose setting mechanism 4 must be re-connected to the cartridge holder 6. When re-connecting these two components, the process generally works in reverse. However, this time the axial compression of the main spring 60 causes the first driver portion 44 to re-engage with the second driver portion 46. In this manner, the flexible elements re-engage with the second annular ring 94 on the second driver portion 46.
  • FIG 6 illustrates a first arrangement of the second driver portion 46 and the first driver portion 44 illustrated in Figures 3 .
  • second driver portion 46 is generally tubular in shape and comprises a first annular groove 90 at a distal end of the second driver portion 46.
  • the first annular groove 90 comprises a conical face 91.
  • the second driver portion further comprises a second annular groove 94 and at least one spline 96 positioned along a surface of the second driver portion.
  • the first driver portion 44 is also generally tubular in shape and comprises a first and a second flexible element 102, 103 and a plurality of spline recesses 100. These plurality of recesses 100 releasably connect the longitudinal spline 96 of the first driver portion 44 to second driver portion 46 when both first and second driver portions 44, 46 are pushed axially together so that they releasably engage one another.
  • the flexible elements 102, 103 of the first driver portion 44 are pushed over the first annular groove 90 of the second driver portion 46 and then stop when the flange 80 of the second driver portion abuts the first axial flange 56 of the first driver portion 44.
  • the first driver portion 44 also includes a plurality of ratchet features 104. These ratchet features 104 are provided at a distal end 106 of the first driver portion 44. These ratchet features 104 engage similar ratchet features on the spring plate 25 which are splined to the housing 2. (See e.g., Figures 3-5 ) At the end of the re-setting step, these ratchet features engage one another so as to prevent the first driver portion 44 from rotating. This ensures that as the spindle 42 is reset further, the first driver portion moves axially to re-engage the second driver portion 46 rather than rotate on the conical face 90. These features also orientate the spring plate 25 relative to the second driver portion 44 so that the two driver portions 44, 46 engage easily during assembly or after reset. Therefore, these ratchet features also prevent the coupling features 100, 96 from clashing with one another.
  • FIG. 8 illustrates a section view of a second arrangement of a dose setting mechanism 200.
  • dose setting mechanism 200 may include a connection mechanism for releasably connecting to a cartridge holder, like the cartridge holder 6 illustrated in Figure 2 .
  • the dose setting mechanism may also include a permanent connection mechanism for permanently connecting to a cartridge holder.
  • Figure 9 illustrates a portion of the dose setting mechanism illustrating the driver operation.
  • Figure 10 illustrates a close up view of the coupling between the first driver portion and the second driver portion illustrated in Figure 9 .
  • the second arrangement of the dose setting mechanism 200 operates in generally a similar fashion to the first arrangement of the dose setting mechanism 4 illustrated in Figures 1-5 .
  • the dose setting mechanism 200 comprises a dose dial grip 202, a spring 201, an outer housing 204, a clutch 205, a driver 209, a number sleeve 206, a clicker 220 and an inner housing 208.
  • driver 209 of dose setting mechanism comprises a first driver portion 207 and a second driver portion 212.
  • the first driver portion 207 comprises a first component part 210 and a second component part 211.
  • the first driver portion 207 is an integral component part.
  • the driver 209 is de-coupled from the dose setting mechanism 200 when the first driver portion 207 is pushed axially towards the second driver portion 212 (i.e., pushed in a proximal direction). In one arrangement, this may be achieved by pushing axially on a distal end of the spindle 214. This does not require any mechanism associated with removal of a cartridge holder.
  • the mechanism is also designed such that the first and second driver portions 207, 212 and the spindle 214 remain locked together rotationally during dose setting as well as during dose administration.
  • This axial movement of the first driver portion 207 towards the second driver portion 212 results in certain advantages.
  • one advantage is that the metal spring 201 will compress and will therefore close the Gap a illustrated in Figures 8-10 . This in turn prevents the clutch 205 from disengaging from the clicker 220 or from the number sleeve 206.
  • a distal end of the clutch 205 comprise a plurality of clutch teeth 203. These clutch teeth 203 engage a plurality of clicker teeth 222 disposed at a proximal end of the clicker 220. As such, when a user dials a dose, these clutch and clicker teeth engage one another to produce a click.
  • the clicker teeth 222 are disposed such that each click corresponds to a conventional unit dose, or the like. Therefore, when the dose dial grip 202 and hence the clutch 205 are rotated, an audible sound is heard as the clutch teeth ride 203 over the clicker teeth 222.
  • the second driver 212 is prevented from rotating since it is splined to the clutch 205.
  • the clicker 220 comprises a plurality of splines 221a, b. These splines 221a, b are splined to an inner surface of the inner housing 208. Therefore, when the Gap a is reduced or closed up, the second driver portion 212 cannot rotate relative to either the housing 204 or the number sleeve 206. As a consequence, the number sleeve 206 cannot rotate relative to the housing 204.
  • the user applies an axial load to a dose button 216.
  • the dose dial grip 202 is rotatably coupled to the dial sleeve and non-rotatably coupled to the dose button 216.
  • the dose button 216 is axially coupled to the clutch 205 and this prevents relative axial movement. Therefore, the clutch 205 moves axially towards the cartridge end or the distal end of the dose setting mechanism 200. This movement disengages the clutch 205 from the number sleeve 206, allowing for relative rotation while closing up the Gap a.
  • the metal spring 201 is selected to be strong enough to maintain engagement of both clutched couplings: the clutched coupling between the clutch 205 and the number sleeve 206 and clutched coupling between the first driver portion 207 and second driver portion 212.
  • Figure 11 shows in detail of a first arrangement of the first driver portion 207 and the second driver portion 212 illustrated in Figure 8 .
  • the second driver portion 212 is generally tubular in shape and comprises at least one drive dog 250 located at a distal end of the second driver portion 212.
  • the first driver portion 207 also has a generally tubular shape and comprises a plurality of recesses 252 sized to engage with the drive dog 250 on the second driver portion 212.
  • the construction of the drive dog and recesses allow disengagement with the drive dog 250 when the first and second driver portions are axially pushed together. This construction also creates a rotational coupling when these components are sprung apart.
  • a dose limiter may be provided on first driver portion 207 and operates similarly to the dose limiter 38 illustrated in Figure 3 .
  • the first driver portion 207 comprises a first portion 211 that is permanently clipped to a second portion 210.
  • the first portion 211 comprises the drive dogs 252 and the second component 210 includes the outer groove for the last dose nut as well as an internal groove 254. This internal groove 254 is used to connect to the spindle 214 and drives the spindle 214 during dose administration.
  • the internal groove 254 comprises a part helical groove rather than a complete helical groove.
  • One advantage of this arrangement is that it is generally easier to manufacture.
  • the dose setting mechanism 200 has a reduced number of components over other known dose setting mechanisms.
  • all of these components making up the dose setting mechanism 200 may be injection molded using inexpensive and unsophisticated tooling.
  • these components making up the dose setting mechanism 200 may be injection molded without the expense and sophistication of a rotating core.
  • a dose setting mechanism 200 comprising an inner housing 208 such as that illustrated in Figures 8-11 is that the dose setting mechanism 200 can be designed, with a slight modification, as a drug delivery device platform that is now capable of supporting both re-settable and non-resettable drug delivery devices.
  • the first driver portion 211 and 210 and the second driver portion 212 can be molded as one unitary part. This reduces the total number of drug delivery device components by two. Otherwise, the drug delivery device illustrated in Figures 8-11 could remain unchanged. In such a disposable device, the cartridge holder would be fixed to the housing or alternatively, made as a single one piece body and cartridge holder.
  • FIG. 8-11 shows an inner housing 208 having a length "L” 230 generally similar in overall length to the dose setting mechanism 200 (cf. Figures 12 , 13 ).
  • providing the inner housing 208 with a length of "L” has a number of advantages over other known dose setting mechanisms that do not utilize an inner body or an inner body having a length generally equal to that of the length of a dose setting mechanism.
  • the inner housing 208 comprises a groove 232 provided along an external surface 234 of the inner housing.
  • a groove guide 236 provided on an inner surface 238 of the number sleeve 206 is rotatably engaged with this groove 232.
  • this dose setting mechanism 200 utilizing the inner housing 208 is that the inner housing 208 can be made from an engineering plastic that minimizes friction relative to the number sleeve 206, groove guide 236 and the groove 232.
  • an engineering plastic could comprise Acetal.
  • other comparable engineering plastics having a low coefficient of friction could also be used.
  • Using such an engineering plastic enables the material for the outer housing 204 to be chosen for aesthetic or tactile reasons with no friction related requirements since the outer housing 204 does not engage any moving components during normal operation.
  • the inner housing 208 also enables the number sleeve 206 to be provided with a helical groove on an inner surface 238 of the number sleeve 206, rather than providing such a helical groove on an external surface 240 of the number sleeve 206.
  • Providing such an internal groove results in a number of advantages. For example, this results in the advantage of providing more surface area along the outer surface 240 of number sleeve 206 so as to provide the scale arrangement 242. More number sleeve surface area may be used for drug or device identification purposes.
  • Another advantage of providing the helical groove 236 on the inner surface 238 of the drive sleeve 206 is that this inner groove 236 is now protected from dirt ingress.
  • the effective driving diameter (represented by 'D') of the grooved interface between the number sleeve 206 and the inner housing 208 is reduced compared to certain known drug delivery devices for the same outer body diameter. This improves efficiency and enables the drug delivery device to function with a lower pitch (represented by 'P') for this groove and groove guide connection.
  • 'P' a lower pitch
  • the number sleeve 206 can be made the length of the mechanism "L" 230 rather than having to split this length into the space required for the number sleeve 206 and a space required for a clicker and a dose limiter.
  • One advantage of this configuration is that it ensures a good axial engagement between the number sleeve 206 and the outer housing 204. This improves the functionality (and perceived quality) of the dose setting mechanism when a user uses the drug delivery device to dial out a maximum settable dose.
  • Figure 13 illustrates the dose setting mechanism 200 dialed out to a maximum settable dose of 80 International Units ("IU").
  • Another advantage is that it enables the scale arrangement 242 to be hidden within the outer housing 204 even when the number sleeve 206 is fully dialed out as may be seen from Figure 13 .
  • the design does not limit the position of the window 14 to that shown in Figure 8 but allows this window 14 to be positioned at near the dose dial grip 202 of the device. In arrangements illustrated in Figure 12 and 13 , the scale arrangement 242 will only be visible by way of the window 14.
  • the driver 209 (whether made in two portions or just one unitary component) can be made with a plain internal through hole plus a thread form that can be molded with axially moving core pins. This avoids the disadvantage of a driver having an internal thread with more than one turn and therefore requires a core pin to be rotated out several turns during a de-molding process.
  • a dose setting mechanism comprising the inner housing 208
  • the use of the inner housing 208 adds a component part to the overall dose setting mechanism 200. Consequently, this inner housing 208 will tend to increase the overall wall thickness that must be designed to fit between the clutch 205 and number sleeve 206.
  • One way to work around this design issue, as illustrated in Figure 8 is to reduce the diameter of the clutch 205 and number sleeve 206.
  • the thread form between the driver 209 and the spindle 214 comprises a male internal feature on the driver 209 and a female external groove form on the spindle 214 that are overlapping with (on a similar diameter with) the spindle groove form that interfaces with the groove along the inner surface 234 of the inner housing 208 or body portion.
  • the overlapping of groove forms on the spindle 214 reduces the effective diameter of the thread interface with the driver 209. This also reduces the potential outer diameter of the driver 209 enabling the addition of the inner housing 208 without increasing the overall outer diameter of the dose setting mechanism 200. Another added benefit of the reduced effective diameter of the thread interface with the driver 209 is that it improves efficiency of the drug delivery device during dispense as explained above.
  • the window 244 through which the scale arrangement 242 may be viewed can either be just an aperture in the outer housing 204 or can include a clear lens or window designed to magnify the scale arrangement (i.e., printed or laser marked dose numbers) along a portion of the outer surface 240 on the number sleeve 206.
  • connection of a cartridge holder into the outer housing 204 can be achieved using either a screw or bayonet type connection.
  • any similarly robust design used in drug delivery devices requiring a largely cylindrical part to be removed and then reattached could also be used.

Claims (21)

  1. Mécanisme de réglage de dose pour un dispositif d'administration de médicament, ledit mécanisme comprenant un logement extérieur (40 ; 204), un logement intérieur (208), un dispositif d'entraînement (30 ; 209) et un manchon de définition (10 ; 206) disposé entre ledit logement extérieur et ledit logement intérieur, dans lequel le logement intérieur comporte une rainure extérieure (232), ledit logement intérieur étant accouplé de manière fonctionnelle avec le dispositif d'entraînement (30 ; 209) et guidant ledit dispositif d'entraînement afin de distribuer une dose réglée par ledit mécanisme de réglage de dose et dans lequel ledit manchon de définition est en prise de manière rotative avec ladite rainure extérieure dudit logement intérieur et dans lequel
    un élément de préhension de définition de dose (12 ; 202) est accouplé de manière rotative avec ledit manchon de définition (10 ; 206), ledit élément de préhension de définition de dose étant accouplé de manière non rotative à un bouton de dose (5 ; 216), de telle sorte que, lorsqu'une dose est réglée par rotation dudit élément de préhension de définition de dose dudit mécanisme de réglage de dose, ledit manchon de définition soit mis en rotation par rapport à la fois audit logement extérieur et audit logement intérieur et ledit manchon de définition soit éloigné par translation à la fois du logement extérieur et du logement intérieur.
  2. Mécanisme de réglage de dose selon la revendication 1, dans lequel une broche (42 ; 214) destinée à agir sur un bouchon de cartouche (18) est prévue, le dispositif d'entraînement (30 ; 209) coopérant avec ladite broche, et le logement intérieur comportant une surface intérieure commandant le déplacement dudit dispositif d'entraînement au cours d'une étape de distribution de dose de telle sorte que ladite broche agisse sur ledit bouchon de cartouche.
  3. Mécanisme de réglage de dose selon la revendication 1 ou 2, dans lequel un embrayage (26 ; 205) accouplé de manière fonctionnelle avec ledit manchon de définition (10 ; 206) et ledit dispositif d'entraînement (30 ; 209) est prévu, ledit embrayage permettant audit manchon de définition et audit dispositif d'entraînement de tourner conjointement au cours d'un réglage d'une dose dudit dispositif d'administration de médicament, et ledit embrayage permettant une rotation relative dudit dispositif d'entraînement et dudit manchon de définition au cours d'une injection de ladite dose.
  4. Mécanisme de réglage de dose selon l'une quelconque des revendications 1 à 3, le mécanisme de réglage de dose étant configuré de telle sorte que, lorsqu'une dose est réglée par ledit mécanisme de réglage de dose, ledit manchon de définition (10 ; 206) et ledit dispositif d'entraînement (30 ; 209) soient tous les deux mis en rotation par rapport à la fois audit logement extérieur (40 ; 204) et audit logement intérieur (208) et soient éloignés par translation à la fois dudit logement extérieur et dudit logement intérieur.
  5. Mécanisme de réglage de dose selon l'une quelconque des revendications 1 à 4, dans lequel ledit élément de préhension de définition de dose est accouplé de manière non rotative au bouton de dose (5 ; 216), de telle sorte que, lorsqu'une dose est réglée par rotation dudit élément de préhension de définition de dose dudit mécanisme de réglage de dose, ledit manchon de définition soit mis en rotation par rapport à la fois audit logement extérieur et audit logement intérieur et ledit manchon de définition soit éloigné par translation à la fois dudit logement extérieur et dudit logement intérieur tandis que ledit bouton de tourne pas.
  6. Mécanisme de réglage de dose selon l'une quelconque des revendications 1 à 5, dans lequel ledit logement intérieur (208) comprend une surface intérieure (238), ladite surface intérieure comprenant une configuration mécanique qui guide ledit dispositif d'entraînement (30 ; 209) afin de distribuer ladite dose réglée par ledit mécanisme de réglage de dose.
  7. Mécanisme de réglage de dose selon la revendication 6, dans lequel ladite configuration mécanique dudit logement intérieur (208) comprend une cannelure qui guide ledit dispositif d'entraînement (30 ; 209) afin de distribuer ladite dose réglée par ledit mécanisme de réglage de dose.
  8. Mécanisme de réglage de dose selon la revendication 6, dans lequel ladite configuration mécanique dudit logement intérieur (208) comprend une rainure qui guide ledit dispositif d'entraînement (30 ; 209) afin de distribuer ladite dose réglée par ledit mécanisme de réglage de dose.
  9. Mécanisme de réglage de dose selon l'une quelconque des revendications 1 à 8, dans lequel ladite rainure extérieure (232) dudit logement intérieur (208) comprend une rainure hélicoïdale présentant un pas constant.
  10. Mécanisme de réglage de dose selon l'une quelconque des revendications 1 à 9, dans lequel ledit manchon de définition (10 ; 206) comporte une surface extérieure (240) globalement lisse.
  11. Mécanisme de réglage de dose selon la revendication 10, comprenant un système de graduation (16 ; 242) prévu le long d'une partie de ladite surface extérieure globalement lisse.
  12. Mécanisme de réglage de dose selon la revendication 11, dans lequel ledit système de graduation (16 ; 242) prévu le long de ladite partie de ladite surface extérieure globalement lisse est visible uniquement à travers une fenêtre (14 ; 244) prévue dans un logement extérieur (40 ; 204) dudit mécanisme de réglage de dose.
  13. Mécanisme de réglage de dose selon l'une quelconque des revendications 1 à 12, ledit mécanisme de réglage de dose étant accouplé, de préférence accouplé de manière permanente, avec un support de cartouche (6).
  14. Mécanisme de réglage de dose selon l'une quelconque des revendications 1 à 13, comprenant une broche (42 ; 214) accouplée de manière fonctionnelle avec ledit dispositif d'entraînement (30 ; 209) de telle sorte que, lorsque ledit logement intérieur guide ledit dispositif d'entraînement afin de distribuer ladite dose réglée par ledit mécanisme de réglage de dose, ledit dispositif d'entraînement pousse ladite broche de sorte qu'elle agisse sur un bouchon de cartouche (18) tandis que ladite broche se déplace par translation dans une direction distale afin d'expulser ladite dose de ladite cartouche.
  15. Mécanisme de réglage de dose selon l'une quelconque des revendications 1 à 14, dans lequel la surface intérieure dudit logement intérieur (208) comprend au moins une rainure longitudinale.
  16. Mécanisme de réglage de dose selon l'une quelconque des revendications 1 à 14, dans lequel la surface intérieure dudit logement intérieur (208) comprend au moins une partie d'une rainure hélicoïdale.
  17. Mécanisme de réglage de dose selon l'une quelconque des revendications 1 à 14, dans lequel la surface intérieure dudit logement intérieur (208) comprend un guide de rainure mâle.
  18. Mécanisme de réglage de dose selon l'une quelconque des revendications 1 à 17, dans lequel ladite broche (42 ; 214) comprend au moins une rainure (19), ladite ou lesdites rainures permettant à ladite broche de se déplacer par translation dans une direction distale afin d'expulser ladite dose d'une cartouche (20).
  19. Mécanisme de réglage de dose selon l'une quelconque des revendications 1 à 18, dans lequel le logement intérieur (208) présente une longueur (L, 230) dans sa direction axiale qui est essentiellement égale à la longueur du mécanisme de réglage de dose (4 ; 200), ou du logement extérieur (40 ; 204) ou du manchon de définition de dose (10 ; 206).
  20. Mécanisme de réglage de dose selon l'une quelconque des revendications 1 à 19, prévu pour régler une dose de produit médicamenteux à distribuer à partir d'une cartouche comprenant une formulation pharmaceutique qui contient au moins un composé actif sur le plan pharmaceutique.
  21. Dispositif d'administration de médicament selon la revendication 20, dans lequel le composé actif sur le plan pharmaceutique comprend au moins un élément parmi une insuline humaine ou un analogue ou un dérivé d'insuline humaine, un glucagon-like peptide (GLP-1) ou un analogue ou un dérivé de celui-ci, ou l'exendine-3 ou l'exendine-4 ou un analogue ou un dérivé d'exendine-3 ou d'exendine-4.
EP10722095.6A 2009-06-01 2010-05-28 Boîtier interne pour dispositif d'administration de médicaments Active EP2437819B1 (fr)

Priority Applications (6)

Application Number Priority Date Filing Date Title
PL10722095T PL2437819T3 (pl) 2009-06-01 2010-05-28 Obudowa wewnętrzna urządzenia do podawania leku
EP18150058.8A EP3345639B1 (fr) 2009-06-01 2010-05-28 Boîtier interne pour dispositif d'administration de médicaments
NO10722095A NO2437819T3 (fr) 2009-06-01 2010-05-28
EP10722095.6A EP2437819B1 (fr) 2009-06-01 2010-05-28 Boîtier interne pour dispositif d'administration de médicaments
PL18150058T PL3345639T3 (pl) 2009-06-01 2010-05-28 Obudowa wewnętrzna urządzenia do podawania leku
DK18150058.8T DK3345639T3 (da) 2009-06-01 2010-05-28 Inderhus til lægemiddeldispenseringsanordning

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US18281809P 2009-06-01 2009-06-01
EP09009042 2009-07-10
PCT/EP2010/057456 WO2010139629A1 (fr) 2009-06-01 2010-05-28 Boîtier interne pour dispositif de distribution de médicament
EP10722095.6A EP2437819B1 (fr) 2009-06-01 2010-05-28 Boîtier interne pour dispositif d'administration de médicaments

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EP18150058.8A Division EP3345639B1 (fr) 2009-06-01 2010-05-28 Boîtier interne pour dispositif d'administration de médicaments
EP18150058.8A Division-Into EP3345639B1 (fr) 2009-06-01 2010-05-28 Boîtier interne pour dispositif d'administration de médicaments

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EP2437819A1 EP2437819A1 (fr) 2012-04-11
EP2437819B1 true EP2437819B1 (fr) 2018-02-21

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PL3345639T3 (pl) 2020-06-15
EP3345639B1 (fr) 2019-12-04
ES2670268T3 (es) 2018-05-29
MX2011012703A (es) 2012-01-20
US8672896B2 (en) 2014-03-18
RU2537057C2 (ru) 2014-12-27
EP2437819A1 (fr) 2012-04-11
AU2010255804A1 (en) 2011-12-22
US20100324493A1 (en) 2010-12-23
KR101876778B1 (ko) 2018-07-10
CA2762012A1 (fr) 2010-12-09
CN102458526A (zh) 2012-05-16
US11654243B2 (en) 2023-05-23
BRPI1015142A2 (pt) 2016-12-06
DK3345639T3 (da) 2020-03-02
HUE037391T2 (hu) 2018-08-28
RU2011154136A (ru) 2013-07-20
CA2762012C (fr) 2017-10-03
AU2010255804B2 (en) 2014-12-18
US20120157929A1 (en) 2012-06-21
BRPI1015142B8 (pt) 2021-06-22
TR201807043T4 (tr) 2018-06-21
IL216434A0 (en) 2012-03-01
JP2012528618A (ja) 2012-11-15
US9125993B2 (en) 2015-09-08
NO2437819T3 (fr) 2018-07-21
DK2437819T3 (en) 2018-06-06
US20150328410A1 (en) 2015-11-19
BRPI1015142B1 (pt) 2021-03-23
IL216434A (en) 2015-01-29
WO2010139629A1 (fr) 2010-12-09
US20190351145A1 (en) 2019-11-21
ZA201107690B (en) 2012-07-25
JP5636424B2 (ja) 2014-12-03
CN102458526B (zh) 2016-10-12
EP3345639A1 (fr) 2018-07-11
US10391254B2 (en) 2019-08-27
TW201107006A (en) 2011-03-01
TWI589320B (zh) 2017-07-01
KR20120028895A (ko) 2012-03-23
PL2437819T3 (pl) 2018-08-31
SG10201402646YA (en) 2014-10-30
NZ596699A (en) 2014-01-31
MY155162A (en) 2015-09-15
AR076608A1 (es) 2011-06-22
SG176079A1 (en) 2011-12-29

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